Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:

Number of warfarin adjustments required in each phase

Time in therapeutic, sub-, and supra-therapeutic range

Variance/SD of INRs for each patient

Adherence assessed by pill counts and pharmacy record review

Thrombotic/bleeding episodes

Enrollment:

15

Study Start Date:

October 2005

Study Completion Date:

May 2006

Primary Completion Date:

May 2006 (Final data collection date for primary outcome measure)

Detailed Description:

Consistent daily Vitamin K intake may contribute to the stabilization of INR values in patients with unstable INRs on warfarin therapy. Subjects with unstable INRs will be identified from the existing patient records of the UNC Anticoagulation Clinics. Eligible subjects will sign an informed consent form and will receive a point-of-care (POC) INR monitoring device. They will undergo 9 weeks of home INR monitoring via the POC device (with monthly clinic follow-up). They will subsequently be provided with 500 mcg Vitamin K tablets to be taken once daily. Weekly POC INR monitoring with monthly clinic follow-up will continue for an additional 8 weeks.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patient of UNC Anticoagulation Clinic with INR target of 2.0-3.0 and at least 9 months on uninterrupted warfarin

Unstable INRs for the past 6 months, defined as a minimum number of warfarin dose changes of 3

Patient demonstration of proper POC device technique on 2 measurements during one teaching session with investigator

Age greater than or equal to 18 years

Exclusion Criteria:

Stroke or TIA within the previous 12 months

VTE within the last 3 months

Antiphospholipid antibody syndrome

Pregnant patients, since warfarin is contraindicated during pregnancy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00287313